Milan – October 09, 2026 -- WuXi Biologics is pitching a European manufacturing footprint of 54,000 L of drug-substance capacity in Dundalk, Ireland, plus a 12,000 L site in Wuppertal, Germany, to biopharma clients at CPHI Milan 2026, as Europe's biologics market is projected to grow from an estimated US$123.75 billion in 2025 to about US$269.65 billion by 2035.
The market is forecast to expand at a CAGR of 8.1% from 2026 to 2035. CPHI Milan 2026 brings together more than 62,000 pharmaceutical professionals and 2,900 exhibitors.
Dundalk hub runs 54,000 L across perfusion and fed-batch platforms
The Dundalk site operates under an HPRA GMP manufacturing license, supports EMA-approved commercial products and has served more than 10 clients. In 2026, it secured multiple new large-scale manufacturing projects and began the associated technology transfers.
Across multiple programs, the site has handled same-scale, scale-up and process-enhancement transfers under the company's Global Dual Sourcing strategy. WuXi Biologics says product comparability and quality standards were maintained. The site won the ISPE Facility of the Year Award in 2023, and in 2026 WuXi Biologics Ireland received the Overall Excellence in Life Sciences Award, while its MSAT team was named Life Sciences Team of the Year.
Wuppertal site offers 12,000 L single-use capacity with room to double
The Wuppertal site in North Rhine-Westphalia currently has 12,000 L of single-use bioreactor capacity, with potential expansion to 24,000 L. It supports clinical, late-stage and commercial programs, and includes GMP-certified quality-control laboratories and integrated warehousing.
Global network spans five countries to address single-site dependency
WuXi Biologics operates manufacturing in Ireland, Germany, the United States, China and Singapore under unified quality systems. Global Dual Sourcing aligns quality, analytics and technology transfer across sites, so customers can compare manufacturing pathways by scale, market needs and supply strategy. The company frames this as a response to client scrutiny of supplier concentration and single-site dependency.
Company reports 49 regulatory inspections passed as of June 2026
As of June 2026, the company had passed 49 regulatory inspections, 23 of them by the FDA and EMA. It also reports 166 facility license approvals and more than 2,000 GMP quality audits by global clients, including over 280 by EU Qualified Persons.
Portfolio of 1,064 integrated projects skews toward complex modalities
The portfolio includes 221 bispecific and multi-specific antibody projects and 328 ADC projects. Complex modalities account for more than half of all projects.
The company reports more than 66 DNA-to-IND projects completed within six months, a 100% IND-filing success rate and project initiation within four weeks. Technology transfer to PPQ has been completed in as little as 3.5 months, with a 100% PPQ campaign success rate. It has scheduled 34 PPQs for 2026 and 30 for 2027.
Cell-line and formulation platforms target titer and concentration benchmarks
The WuXiaTM TrueSite cell-line platform has achieved titers of 8-12 g/L for monoclonal antibodies and 7-10 g/L for bispecific antibodies. More than 99% of clonal cell lines kept stable expression after 60 generations, and the platform supports an IND-ready CMC timeline within six months.
WuXiHighTM 2.0 supports protein concentrations up to 240 mg/mL and viscosity reductions of up to 90% for subcutaneous therapies. It links high-throughput formulation with fill-finish, drug-device combination and large-volume delivery options.